D-0090-2022 Class II Terminated
FDA drug recall D-0090-2022 was initiated by Lupin Pharmaceuticals Inc. on Oct 12, 2021 and is designated Class II. Reason for recall: CGMP Deviations: impurity N-nitrosoirbesartan detected in API The recall status is terminated (terminated Jan 30, 2023). Affected quantity: 98,052 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 10, 2021
- Initiation Date
- Oct 12, 2021
- Termination Date
- Jan 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,052 bottles
Product Description
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Distribution Pattern
Product was distributed to major distributors who may have further distributed the product nationwide.
Code Information
a) Lot# H804192, exp. date 31/08/2021 H805348, exp. date 30/11/2021 H900065, exp. date 31/12/2021 H902264; exp. date 31/05/2022 b) Lot# H804082, exp. date 31/08/2021 H804121, exp. date 31/08/2021 H804338, exp. date 31/08/2021 H804538, exp. date 30/09/2021 H804539, exp. date 30/09/2021 H805349, exp. date 30/11/2021 H805350, exp. date 30/11/2021 H900066, exp. date 31/12/2021 H900067, exp. date 31/12/2021 H902265, exp. date31/05/2022 H902275, exp. date31/05/2022 H902276, exp. date31/05/2022 H902531, exp. date 30/04/2022 H902532, exp. date 30/04/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0090-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026